Protara Updates TARA-002 Clinical Data
Protara Therapeutics announced updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS non-muscle invasive bladder cancer. These results in Bacillus Calmette-Guerin-Naive NMIBC patients will be featured today during a poster session at the American Urological Association annual meeting in Washington, D.C. The BCG-Naive dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5 data cutoff. The CR rate at any time in BCG-Naive patients was 72.4%. The CR rate in BCG-Naive patients was 66.7% at six months and 55% at 12 months. The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1%. Overall, 91.7% maintained their CR from nine to 12 months. Overall, 66.7% of re-induced patients converted to a CR at six months. The majority of treatment-related adverse events were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.
